MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24692
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: event date was not reported and was approximated to (b)(6) 2020.
Event or Problem Description
It was reported that the balloon ruptured.A 3.5mm x 80mm x 150cm sterling sl balloon dilatation catheter was selected for a plain old balloon angioplasty (poba) procedure in the severely calcified below-the-knee (btk) vessel.During the procedure, the balloon ruptured when inflated to 4-6 atmospheres.The device was removed and the procedure was completed with another of the same device.No patient complications were reported, and the patient was in stable condition post-procedure.
Additional Manufacturer Narrative
B3 date of event: event date was not reported and was approximated to (b)(6)2020.Device evaluated by manufacturer:the device was returned for analysis.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.There was a circumferential tear 44mm from the proximal marker band and at the distal marker band.There was no marker band damage detected.Approximately 34mm of the balloon was detached and not returned.The balloon rupture was confirmed.
Event or Problem Description
It was reported that the balloon ruptured.A 3.5mm x 80mm x 150cm sterling sl balloon dilatation catheter was selected for a plain old balloon angioplasty (poba) procedure in the severely calcified below-the-knee (btk) vessel.During the procedure, the balloon ruptured when inflated to 4-6 atmospheres.The device was removed and the procedure was completed with another of the same device.No patient complications were reported, and the patient was in stable condition post-procedure.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10505718
• Report Number: 2134265-2020-12238
• Device Sequence Number: 3033064
• Product Code: LIT
• UDI-Device Identifier: 08714729782742
• UDI-Public: 08714729782742
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2022
• Device Model Number: 24692
• Device Catalogue Number: 24692
• Device Lot Number: 0025552407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1